Actively Recruiting
Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level
Led by Postgraduate Institute of Dental Sciences Rohtak · Updated on 2025-09-11
81
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The classical idea was to keep the biologic width untouched in order to maintain periodontal health but the newer case reports have given a new dimension to this concept, stating that a limited extension into STA can be used as an alternative for invasive procedures like SCL. The periodontal tissues can still tolerate subgingival margin placement in biologic width when restorations are free of overhangs which are real culprit for providing room for plaque retention and further inflammation. There are no sufficient clinical studies with good sample size to prove the significance of this concept. Hence, we are performing a Non Randomized Controlled trial by placing gingival margins at various levels above the alveolar crest and restoring it with composite and further evaluate the periodontal tissue health, pulpal health, restoration quality and significance of DME.
CONDITIONS
Official Title
Impact of DME on Pulpal and Periodontal Health at Varying Gingival Seat Level
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older at the time of treatment
- Permanent back teeth with proximal cavities extending below the cemento-enamel junction
- Axial extent of cavity not exceeding 75% of dentin thickness
- At least 1mm of healthy tooth structure from alveolar crest to cavity base after preparation
- Teeth without symptoms or with reversible pulpitis only, no spontaneous or lingering pain
- Periodontally healthy teeth
- Full mouth plaque and bleeding scores of 15% or less
You will not qualify if you...
- Presence of bone diseases including metabolic, endocrine, infectious, tumoral, or developmental conditions
- Pregnancy, lactation, history of smoking, or alcohol abuse
- Use of anti-inflammatory drugs within the past 3 days
- Uncontrolled or poorly controlled diabetes
- Life-threatening conditions or need for antibiotic prophylaxis
- Detectable plaque or bleeding on probing at the tooth to be treated
- Thin gingival tissue, periodontitis, or gum recession
- Class II cavities with gingival margin above the cemento-enamel junction
- Previously restored teeth
- Missing adjacent tooth, opposing tooth, or crown on adjacent tooth
- History of teeth grinding (bruxism) or dry mouth (xerostomia)
- Need for gum surgery (gingivectomy)
- Inability to isolate the tooth with a rubber dam
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Trial Site Locations
Total: 1 location
1
PGIDS
Rohtak, Haryana, India, 124001
Actively Recruiting
Research Team
D
Dr. Mayank Arora
CONTACT
D
Dr. Swathi C
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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